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The voice for pharmacy compounding | February 19, 2021

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From APC's President: Uncle Mike wants YOU!


Michael Blaire, RPh, FIACP
APC President

Dear A4PC,

World War I produced one of the most memorable images in American history: the U.S. Army recruiting poster that depicts a commanding Uncle Sam pointing his finger and urging young men to enlist in the war effort: I want YOU for U.S. Army, it read. More than four million copies of it were printed between 1917 and 1918. Ultimately, more than 4.7 million men and women served.

Yesterday APC issued a call to action: We need YOU to talk about MOU.

Never mind that pharmacy compounders have been discussing the MOU since the passage of the DQSA in 2013. The majority of state Boards of Pharmacy and many compounding pharmacy owners are still unaware of the devastating consequences the MOU could have on your patients and your business. It is up to you to make sure you know the facts and that you communicate them clearly and emphatically to your state Board.

What are the facts?

In states that do sign, the MOU conflates definitions of 'distribute' and 'dispense' in a way Congress never anticipated. As a result, FDA will gain oversight of certain aspects of traditional prescription dispensing. Furthermore, if a pharmacy ships more than 50 percent of its compounded prescriptions out of state, specific reporting requirements are imposed. FDA seriously underestimated the administrative burden on states, such as the costs of staffing, reporting, etc., required for compliance. In effect, the MOU creates an unfunded mandate on states that sign.

In states that do not sign, it's worse. Pharmacies will be limited to shipping NO MORE THAN FIVE PERCENT of their compounded preparations out of state. If you make 10 compounds a day, and ship one out of state, you will have already exceeded the five percent cap and will have violated FDA regs. That five percent cap could impede countless patients from getting their medications and might even put some compounders out of business. Remember, it doesn't matter if you ship less than five percent of your compounded prescriptions out of state, it matters if you ship more than five percent.

APC wants YOU to contact your state board of pharmacy and ask them to reach out NOW to FDA and the National Association of Boards of Pharmacy with their concerns about signing the MOU.

We have made it simple. Here is a template letter that you can customize with your pharmacy-specific details, then copy and paste it into an email or onto letterhead. We also have the contact information for each state pharmacy board.

If you have already taken action, thank you. Now call a competitor and tell them to do the same.

If you have not already contacted your state board, do so immediately. Uncle Sam got 4.7 million men and women to take action. We only need 50 state boards of pharmacy to do so.


Michael Blaire is APC's president; his day job is vice president for government and regulatory affairs at Wedgewood Pharmacy in Scottsdale, Arizona. You can reach him at mblaire@wedgewoodpharmacy.com.



Owner Summit: It's not personal. It's business.

IMPORTANT: The Westin has sold out
for Saturday night, March 27
.

There are rooms available at the nearby Hampton Inn for those who wish to stay over on Saturday.
Information is available on the Owner Summit Web page.

APC's first-ever Compounding Pharmacy Owner Summit is where owners and managers like you can discover business ideas, solutions, and new opportunities that can boost your businesses.

Tap the big green button below to see the program, then register — and remember, book your room at the Westin ASAP! — special APC hotel rates there are only guaranteed for reservations made by February 26.

APC joins on amicus brief

A group of five organizations, led by APC, this week filed a “friend-of-the-court” brief in support of litigation challenging FDA’s MOU with states. That litigation was filed in federal court in October 2020 by seven compounding pharmacies, alleging the final MOU is flawed both substantively and procedurally.

Joining APC on this week’s amicus filing are Central Admixture Pharmacy Services, Professional Compounding Centers of America, National Community Pharmacists Association, Nutrishare, and Medisca USA.

Read the entire brief here (PDF).

The amicus was filed on APC’s behalf by Karla L. Palmer of Hyman, Phelps & McNamara, P.C. Funding for the amicus filing comes in part from APC’s Legal Action Fund, which is supported by APC member contributions.

They downloaded the Code — have you?

Have you downloaded the new APC Compounder's Code of Ethics? Central Compounding in Durham, NC, and Stanley Compounding in Charlotte, NC, did, and they're displaying it proudly. You can, too. Download the code at A4PC.org/downloadthecode.

And don't forget you can also watch and share Jon Pritchett's powerful video, "The APC Code of Ethics: Ensuring Your Reputation and Legal Standing" on APC's updated Code of Ethics page.

cBHT media campaign briefing is next Thursday

Don't forget to mark your calendar for February 25 at 3:00pm (EST) for APC's Town Hall briefing with an update on our multi-pronged, multi-year media campaign to save cBHT.

The campaign launches next month, and we've raised more than $556,000 toward our $1.5 million goal. We've started production on print ads, video presentations, websites, and more.

Get a sneak peek at those ad designs, the new website, and our plans for the next six months — plus an update on the production and fundraising.

The Town Hall is just one hour, via Zoom. It's free and open to all, but you need to register: A4PC.org/225townhall.


A big town hall for APC's District II

If you're a compounder in the Northeast/Mid-Atlantic (Maine to DC) please join us for a virtual town hall on compounding issues: Wednesday, March 10 from 4:00-5:00pm EST.

This APC District II meeting is free and open to all compounding professionals — no registration required. It's a perfect chance to hear about the issues facing compounding, and to meet and connect with other folks in your neck of the woods.

On March 10, just go to A4PC.org/310townhall to attend, or call in to (312) 626 6799.

Meeting ID: 818 1287 3996
Passcode: 812010
Or just click here on your mobile: +13126266799,,81812873996#,,,,*812010#

WHAT'LL BE COVERED

In short, what happened in 2020 and what's planned for 2021.

In long, here are the issues we'll be talking about:

And of course there will be plenty of time for Q&A.

Don't miss out — it's free, interesting, informative, and you can attend from your favorite hotspot.

Coming up

February 22; 1:00-2:15pm EST — Institute for Local Self-Reliance free webinar with Congressman David Cicilline, "Reining in Monopoly Power: Small Businesses & the Push to Strengthen Antitrust Laws."

February 23; 1:00 to 2:00pm EST — ARL webinar: Insurance Considerations for Pharmacists and Professional Liability in Compounding

March 2; 2:00-3:00p.m. EST — CE webinar: "Survey of State Compounding Law Changes 2020 and Proposed 2021"

March 26–27, 2021 — APC’s 2021 Compounding Pharmacy Owner Summit

April 6, 7, 8USP webinars on chapters <797>, <800>, and <795>, respectively

June 10–11, 2021 — PCCA Act Conference (virtual)

September 14–15, 2021 — Compounders on Capitol Hill (mark your calendars!)

ICYMI

President Biden will nominate former CMS official Chiquita Brooks-LaSure to oversee the agency.

We've hit the 3,300 3,400 mark (!) for testimonials about the effectiveness of cBHT (from patients, prescribers, and compounders). That sounds like a lot, but we need more! The more testimonials we have for each congressional district, the better, so please continue to spread the word: Go to A4PC.org/cbhtandme and tell us your story!


A4PC.org